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I had planned to use this week's column to explain a new early warning system that tells
us which drugs on the market look as though they're causing health problems.
The idea was for all of us to know that this alarm bell exists and to understand how it
can help us avoid possibly risky medications.

Then I talked to a few doctors and other health experts.

What I've come to realize is that we all need to be aware of this online warning system.
But we also need to understand its flaws and to know that each of us can help fix them, so
that -- in the end -- we're all better off.

Let me explain.

In September, the U.S. Food and Drug Administration started a Web site to tell consumers
about possible safety problems with prescription medications. (You can find it by going to
www.fda.gov and clicking on Adverse Event Reporting System Safety Information.)

Even though drugs are tested before they hit the market, some side effects and safety
issues don't surface until tens of thousands of patients have taken them for months.

The FDA calls the complications "adverse events." And when they show, doctors,
drug makers and patients can register them with the FDA's Adverse Event Reporting System.

The FDA investigates the complaints, determines if they are valid and, if they are, takes
action to keep the rest of us safe. It can, for example, add new warnings to drug labels,
send warning letters to doctors or stop the sale of the drug.

In the past, most of us didn't know about the problem until the FDA took action.

This fall, that changed.

A federal law passed last year requires the FDA to report those complaints on its Web site
every quarter. The first list includes 21 drugs. Some are well-known -- the blood thinners
Warfarin and Heparin and the narcotic OxyContin, for example. And the potential risks
range from confusing labels to cancer and cardiac arrest.

The important word to remember here is "potential."

The Web site makes it perfectly clear that the FDA has not yet proven these drugs cause
the health risk listed.

It also makes clear that just because a drug is listed doesn't mean patients should stop
taking it.

Doctors are worried about that, too.

"That's the most obvious concern that physicians have -- that patients will hear
something about a medication that they're taking and then they'll stop taking it before
talking it over with their physician because they're worried," says Dr. Martin Ryan,
assistant medical director of MetroHealth Medical Center's Buckeye Health Center.

"These are simply cautions, concerns that have been raised. They haven't been fully
investigated."

If a drug you're taking makes the list, talk it over with your doctor. And keep taking it
until you do. That advice is repeated over and over by many people in the health
profession.

Steven Nissen, chairman of the Cleveland Clinic's Department of Cardiovascular Medicine,
goes further than that.

Ignore the list, he says. Don't take it seriously.

"Here's the problem, and this is the crux of the issue," Nissen says.
"These reports are voluntary, and studies have shown that anywhere between 1 percent
and 10 percent of serious adverse events are ever reported to the FDA.

"And when you have a voluntary system like that, you're subject to a number of
nuances. For example, if a drug suddenly gets a lot of public attention, the reporting
goes up.

"Does that mean the drug is unsafe? No.

"It just means that the reporting has gone up."

In addition, he says, adverse events are reported much more frequently on new drugs than
old ones.

"The point of all this is that the Adverse Event Reporting System is a flawed method
for reporting drug safety," Nissen says. "Much better information is going to
come from an enlightened dialogue between patients and doctors. It's the best thing to
do."

For solid information on drugs and their safety, Nissen suggests we rely on Consumers
Union, the nonprofit publisher of Consumer Reports.

The organization, he says, is objective, careful and very credible. You can find its drug
information by going to www.consumerreports.org/health and clicking on Best Buy Drugs.

The information on that Web site is valuable, agrees Lisa McGiffert, senior health policy
analyst for Consumers Union.

But McGiffert also urges all of us to report problems with any medication problems we have
to the FDA. (Go to www.fda.gov/Cder/drugSafety.htm and click on MedWatch.)

There is a value to the FDA Adverse Event Reporting System, she says, especially if all of
us start logging in these adverse events.

"The FDA can't be everywhere," McGiffert says. "It cannot go into every
nook and cranny and know what's going on with every person.

Peppermint oil is effective in treating digestive disorders and other conditions including
headaches, although high dosages may cause adverse effects, according to the results of a
review reported in the April 1 issue of American Family Physician.

"The medicinal use of peppermint and other mint plants probably dates back to the
herbal pharmacopoeia of ancient Greece, where peppermint leaf traditionally was used
internally as a digestive aid and for management of gallbladder disease; it also was used
in inhaled form for upper respiratory symptoms and cough," write Benjamin Kligler,
MD, MPH, from the Albert Einstein College of Medicine of Yeshiva University in New York,
and Sapna Chaudhary, DO, from the Beth Israel Continuum Center for Health and Healing in
New York. "Peppermint oil, which is extracted from the stem, leaves, and flowers of
the plant, has become popular as a treatment for a variety of conditions, including
irritable bowel syndrome (IBS), headache, and non-ulcer dyspepsia."

Specific applications of note are as follows:

Peppermint leaf and oil have a long history of use for digestive disorders.

Peppermint oil has relaxant effects on smooth muscle. When given via enema, it has been
shown to be modestly effective in relieving colonic spasm in patients undergoing barium
enemas (evidence rating, B).
Although peppermint oil is well tolerated at the commonly recommended dosage, it may cause
significant adverse effects at higher dosages. Common adverse effects include allergic
reactions, heartburn, perianal burning, blurred vision, nausea, and vomiting. Interstitial
nephritis and acute renal failure are rare.

Because peppermint oil may inhibit the cytochrome P450 1A2 system, it may interact with
drugs metabolized via this system.

Peppermint oil is contraindicated in patients with hiatal hernia, severe gastroesophageal
reflux, and gallbladder disorders and should be used with caution in pregnant and
lactating women.

The recommended dosage is 0.2 to 0.4 mL of peppermint oil 3 times daily in enteric-coated
capsules for adults, and 0.1 to 0.2 mL of peppermint oil 3 times daily for children older
than 8 years.

Cost is approximately $24 to $32 for a 1-month supply.

"Peppermint oil should not be used internally or on or near the face in infants and
young children because of its potential to cause bronchospasm, tongue spasms, and,
possibly, respiratory arrest," the authors conclude. "However, the amount of
peppermint in over-the-counter medications, topical preparations, and herbal teas is
likely safe in pregnant and lactating women and in young children."
The authors have disclosed no relevant financial relationships.
Am Fam Physician. 2007;75:1027-1030.

Clinical Context
Peppermint has been used as a medicinal substance for thousands of years. Most modern
preparations of peppermint use its oil, which usually is provided with an enteric coating
to prevent gastroesophageal reflux. This oil contains menthol, menthone, cineol, and other
oils, and there is evidence that this combination of compounds can relax gastrointestinal
smooth muscle as well as lower esophageal sphincter pressure.

Peppermint oil has been used to treat not only gastrointestinal complaints but also
headache. The current article reviews the efficacy and safety of peppermint oil for these
indications.

Study Highlights
Peppermint oil appears to be mildly effective in reducing symptoms of IBS, particularly
flatulence, abdominal pain, and distension, in adults. However, there has been significant
heterogeneity among research into this subject.
A study of children between the ages of 8 and 17 years who had IBS found that peppermint
oil was more effective than placebo in reducing the severity of abdominal pain.
2 trials have demonstrated that treatment with peppermint oil reduced the risk for
gastrointestinal spasm during barium enema, with peppermint associated with up to a 3-fold
increase vs placebo in the rate of having a procedure free of spasm.
The combination of 90 mg of peppermint oil plus 50 mg of caraway oil has been demonstrated
to reduce symptoms of nonulcer dyspepsia, including fullness, bloating, and spasm. This
combination should be used cautiously for patients with dyspepsia, as peppermint oil may
promote gastroesophageal reflux.
2 studies have delineated the efficacy of topical peppermint oil in tension headache. In 1
study, a combination of peppermint and ethanol was superior to placebo in terms of
analgesia. Another trial demonstrated that topical peppermint oil was similar to
acetaminophen in terms of treatment efficacy.
The therapeutic dosage in most trials of peppermint oil and IBS was 0.2 to 0.4 mL taken 3
times daily in enteric-coated capsules. The 1 trial examining its use for childhood IBS
used a dosage of 0.1 mL of peppermint oil 3 times daily for children weighing less than 45
kg.
Peppermint oil can be toxic in overdose, leading to interstitial nephritis and acute renal
failure. Because it may promote gallstone formation, it should not be used in patients
with cholelithiasis or cholecystitis. Peppermint oil also may trigger menstruation and
should not be used during pregnancy.
The most common adverse events associated with peppermint oil include allergic reactions,
heartburn, perianal burning, blurred vision, nausea, and vomiting. Peppermint oil may
inhibit the cytochrome P450 1A2 system.
Pearls for Practice
Peppermint oil contains menthol, menthone, and cineol and may work by relaxing smooth
muscle in the gastrointestinal tract. Peppermint oil also may reduce lower esophageal
sphincter pressure and therefore usually is supplied with enteric coating.
Peppermint oil offers mild efficacy for symptoms of IBS and may improve colonic spasm
associated with barium enema. Topical formulations of peppermint oil may improve tension
headache.

Kemal Sagduyu, M.D., Kansas City, Mo.
TO THE EDITOR: I would like to inform practicing psychiatrists about a potentially
effective treatment for irritable bowel syndrome. Irritable bowel syndrome affects a fair
number of patients who visit psychiatric clinics. The classic symptoms of irritable bowel
syndrome symptoms are lower abdominal pain, bloating, and alteration of bowel habits. The
percentage of the population of Western civilization with the symptoms of irritable bowel
syndrome is between 10% and 15%.1 Within the last 2 years, in our mood disorders clinic,
17% of the 72 patients suffering from bipolar mood disorder have reported comorbid
irritable bowel syndrome, diagnosed by their internist or family physician. I began
informing patients who have comorbid irritable bowel syndrome about peppermint oil, a
possible remedy. Seven (of 12) patients with comorbid irritable bowel syndrome have used
it and reported that they felt peppermint oil has helped relieve their irritable bowel
syndrome symptoms, mainly bloating, pain, and discomfort. Patients who benefited were
taking one-half to one full cc (mm) of peppermint oil in a nonalcoholic drink of their
choice after breakfast and dinner.

The first report of the use of peppermint oil for relief of irritable bowel syndrome
symptoms dates back to 1979.2 A report3 has summarized eight randomized, controlled trials
of extracts of peppermint (Mentha piperita L.) as a symptomatic treatment for irritable
bowel syndrome. It noted that peppermint oil could be efficacious for symptom relief in
irritable bowel syndrome. However, citing "methodological flaws associated with most
studies," a definitive judgment about efficacy was not given.3 There also are reports
on the use of an enteric-coated peppermint oil formulation and menthol-beta-D-glucuronide,
a potential prodrug for colonic delivery of the spasmolytic agent menthol, the primary
constituent of peppermint oil. In one study,4 41 patients (79%) taking the formulation
experienced an alleviation of the severity of abdominal pain (29 were pain-free), 43 (83%)
had less abdominal distension, 43 (83%) had less stool frequency, 38 (73%) had fewer
borborygmi, and 41 (79%) had less flatulence.

In a recent randomized, double-blind, controlled trial,5 42 children with irritable bowel
syndrome were given pH-dependent, enteric-coated peppermint oil capsules or placebo. After
2 weeks, 75% of those receiving peppermint oil had reduced pain associated with irritable
bowel syndrome.

Peppermint oil may be used as a therapeutic agent during the symptomatic phase of
irritable bowel syndrome.5 One potential scientific explanation is that peppermint oil is
an inhibitor of K+ depolarization-induced and electrically stimulated responses in the
ileum. Data indicate that both menthol and its constituent, peppermint oil, exert
Ca2+-channel-blocking properties that may underlie their use in irritable bowel syndrome.
Ca2+-channel antagonism may not be the only pharmacological effect of menthol and
peppermint oil contributing to intestinal smooth-muscle relaxation.6

Many patients labeled as having irritable bowel syndrome are in fact intolerant to the
ingestion of lactose-containing foods, sorbitol, fructose, and combinations of fructose
and sorbitol.7 Gastroesophageal reflux, when comorbid with irritable bowel syndrome, is
sometimes treated with the elimination of peppermint from the diet.7 Therefore, patients
should also be seen by a gastroenterologist to help rule out lactose intolerance,
gastroesophageal reflux, and the like.

BRIDGEWATER, N.J. -- Alpharma Inc. has announced the debut of Flector Patch (diclofenac
epolamine topical patch) 1.3%, described as the first prescription anti-inflammatory
pain-relief patch in the United States. The adhesive patch is said to deliver medication
directly to the site of pain, offering a safe and effective alternative to the widely used
nonsteroidal anti-inflammatory drugs (NSAIDs), which are taken orally.

The targeted delivery of the patch through the skin results in minimal systemic absorption
of diclofenac, one of the best-selling and most widely used orally administered NSAIDs
worldwide, asserts Alpharma.

Acute pain is a common problem, with one in four Americans suffering an episode of pain
lasting longer than 24 hours. Flector is indicated for the topical treatment of acute pain
due to minor strains, sprains and contusions.

The patch contains 180 mg of diclofenac, which as a pill is sold under the Voltaren brand
name. The product has been on sale since 1993 outside of the United States.

In a national survey released by the National Pain Foundation (and supported by a grant
from Alpharma) 93% of respondents expressed the belief that people take too many pills,
and 82% said they would be interested in a prescription pain-relief patch that delivers
medication directly to the point of pain. Further reinforcing the need for new pain-relief
therapies, the survey shows that only 22% of the respondents were very satisfied with the
current method they used to treat pain.

This story originally aired in September 2007. In this special edition of FDA PSN, we are
repeating some of the most important safety issues that continue to pose a public health
concern.

A recent report from the Institute for Safe Medication Practices (ISMP) warns about the
dangers of is prescribing fentanyl transdermal patches, such as Duragesic. ISMP reminds
practitioners that these
patches are intended only for patients who are opioid-tolerant, and should not be used for
acute pain.

ISMP also pointed out other prescribing errors. In some cases, deaths occurred in patients
who were prescribed multiple fentanyl patches, resulting in overdose. In other cases the
fentanyl was prescribed in addition to other pain medications, such as oxycodone, or it
was
prescribed for patients with pre-existing respiratory compromise.

ISMP points out that sometimes pharmacists have dispensed these prescriptions without
questioning them, and nurses have applied the patches without recognizing the prescribing
error.

Here are some of ISMP's recommendations to help avoid these tragic and preventable errors:

* Prescribe fentanyl patches only for patients who are opioid tolerant, and who have
chronic pain that is not well-controlled with shorter-acting analgesics. These patches
should not be used for postoperative pain, or for pain that's short-term or intermittent.
Pharmacists should ensure that the patient is opioid-tolerant and suffering from chronic
pain before dispensing the drug, and should question the prescriber if this is not the
case.

* Set dosing limits. For example, pharmacy computer systems could be set to flash an alert
if more than 25 mcg per hour has been prescribed as a first-time dose. Also, in evaluating
whether the dose is appropriate, take into account other opiates or analgesics that may
have been prescribed.

* Educate practitioners and patients to know the signs of overdose, which include
respiratory distress, shallow breathing, fatigue, sleepiness, confusion, dizziness and
fainting.

* Prescribing errors are not the only cause of deaths and injuries from fentanyl patches.
They also occur when patients mis-use the patches. Sometimes patients and family members
do not understand that heat can increase absorption of the drug to dangerous levels. So
patients should be told to avoid heating pads, electric blankets or hot baths while the
patch is in place, and let their doctors know if they develop a temperature above 102
degrees.

* There have also been cases where children found used patches in the trash and applied
them to their own bodies, and died as a result. And so patients should be warned to
dispose of the patches by folding
them in half and flushing them down the toilet.

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